第五套标准重启后 科创板首次受理创新医疗器械企业

Core Viewpoint - Shenzhen Core Medical Technology Co., Ltd. has had its IPO application accepted by the Shanghai Stock Exchange, marking it as the first innovative medical device company to be accepted under the new listing standards of the Sci-Tech Innovation Board [1] Company Overview - Core Medical specializes in the research, development, production, and sales of high-end medical devices in the field of artificial hearts and is recognized as a national high-tech enterprise [1] - The company has received investments from reputable institutional investors such as Hillhouse Capital and Zhengxin Valley [1] Product Development - Core Medical has innovatively applied "time-sharing zoned dynamic axial full magnetic suspension control technology" and "axial magnetic flux multi-drive motor technology" to the field of artificial hearts [1] - The company has developed 5 implantable and 6 interventional artificial heart products, addressing clinical needs from long-term to short-term support and from left heart to dual heart support, as well as from pediatric to adult support [1] - Several core products have entered China's special review process for innovative medical devices, with the number of products ranked first in the artificial heart field in China [1] Market Position - The Corheart® 6, launched in June 2023, is the smallest and lightest commercialized magnetic suspension implantable artificial heart globally, with a projected market share exceeding 45% in 2024 and cumulative implantations surpassing 1,000 [2] - The DuoCor® 2 is expected to be the world's first integrated magnetic suspension dual heart assist system, designed to address the long-term treatment challenges of "total heart failure" [2] - The interventional artificial heart series CorVad® 4.0/6.0 is currently in the registration approval stage and is anticipated to become the first approved interventional artificial heart product in China [2]